Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Trials. 2022 Oct 12;23(1):871. doi: 10.1186/s13063-022-06801-z.
Intracerebral hemorrhage (ICH) is a devastating disease, its mortality and disability rate are high. In China, hypertensive intracerebral hemorrhage (HICH) is responsible for 75% of all the cases of primary ICH. A lot of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating HICH have been carried out. However, these RCTs have a lot of problems, such as heterogeneous outcomes, non-uniform point of measurement. These lead to systematic review/meta-analysis only can include a small number of studies. And outcome measures did not take the wishes of patients and other stakeholders into account. The aim of this study is to establish the core outcome set (COS) for future TCM clinical trials of HICH.
First, we will develop a long list of general outcomes by making systematic literature review and semi-structured interviews. Then healthcare professionals and patients with HICH will be invited to participate in two rounds of the Delphi survey to determine the importance of the outcome. Finally, a face-to-face consensus meeting will be conducted to determine the final COS of HICH, including what outcomes should be measured and when and how to measure the outcomes.
We aim to develop a COS that includes TCM core syndrome for HICH to determine what outcomes should be reported and when and how to measure them.
By doing this, we can increase the reporting consistency and reduce the reporting bias in the outcome, which leads to the reuse of research data in meta-analysis and the making of informed healthcare decisions.
The entire project has received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The final COS will be published and reported at the national and international conferences.
This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1475 . Registered on December 2019.
脑出血（ICH）是一种破坏性疾病，其死亡率和致残率都很高。在中国，高血压性脑出血（HICH）占原发性 ICH 的所有病例的 75%。已经开展了许多中医药治疗 HICH 的随机对照试验（RCT）。然而，这些 RCT 存在很多问题，例如结局不一致、测量点不统一。这导致系统评价/荟萃分析只能纳入少数研究。而且结局指标没有考虑患者和其他利益相关者的意愿。本研究旨在为未来 HICH 的中医药临床试验建立核心结局集（COS）。
首先，我们将通过系统文献回顾和半结构化访谈制定一份一般结局的长清单。然后将邀请 HICH 的医护人员和患者参与两轮 Delphi 调查，以确定结局的重要性。最后，将进行面对面的共识会议，以确定 HICH 的最终 COS，包括应测量哪些结局以及何时以及如何测量这些结局。
我们旨在制定一个包括 HICH 中医核心证候的 COS，以确定应报告哪些结局以及何时以及如何测量这些结局。
通过这样做，可以提高结局报告的一致性，减少报告偏倚，从而促进荟萃分析中研究数据的再利用和明智的医疗决策。
整个项目已获得中国中医科学院西苑医院伦理委员会的批准。最终的 COS 将在国家和国际会议上公布和报告。
本研究在中国临床试验注册中心以研究 1475 号注册。注册于 2019 年 12 月。
